Manometry apparatus for measuring esophageal sphincter compliance

Abstract

An apparatus and method for measuring the compliance of the lower esophageal sphincter (LES), the apparatus including a catheter having a plurality of extendable members for both measuring the compliance of the LES and stimulating the esophagus which relaxes the LES to obtain a more clinically relevant measurement of LES compliance. In one embodiment, the plurality of extendable members include a first balloon which is located and inflated within the esophagus to trigger esophageal motility, a second, non-elastic balloon that is positioned within the LES, and a third balloon which is inflated within the stomach to help align the second balloon with LES. Incrementally increasing volumes of air are introduced into the second balloon, with the resulting pressures exerted by the LES calculated and compared to normative values to assess the condition of the LES.

What is claimed is:  
     
       1. An apparatus for measuring the compliance of a sphincter of a mammal comprising: 
       a compliance measurement catheter further comprising a length of tubing having a first end, a second end, and at least one lumen extending at least substantially therealong;  
       a first extendable member disposed about the length of tubing, the first extendable member sized and configured to such that it is sufficiently extendable to contact the walls of a body lumen proximate the sphincter and cause the sphincter to enter a transient state of relaxation; and  
       a second extendable member located proximate to the first extendable member along the length of tubing, the second extendable member comprising an inflatable member of a material that is substantially non-elastic when the full available volume of the inflatable member is inflated with a fluid, the inflatable member being sized and configured to contact the inner walls of the sphincter in a manner such that the force of the sphincter against the inflatable member results in pressure changes within the inflatable member that are measurable by a manometric measurement port disposed therein, the measurable pressure changes being usable for assessing compliance of the sphincter.  
     
     
       2. The apparatus of  claim 1  wherein the first extendable member comprises an inflatable esophageal balloon disposed along the length of tubing such that the esophageal balloon is located in the esophagus of the mammal when the second extendable member is placed within the lower esophageal sphincter. 
     
     
       3. The apparatus of  claim 1 , further comprising a third extendable member located distal of the first and second extendable members and adapted for correctly positioning the second extendable member within the sphincter following deployment of the third extendable member within the stomach of the mammal. 
     
     
       4. The apparatus of  claim 3 , wherein the third extendable member comprises an inflatable gastric balloon. 
     
     
       5. The apparatus of  claim 1 , wherein the length of tubing further includes at least one manometric measurement port disposed therealong, the at least one manometeric measurement port so positioned for measuring the internal pressure found within at least one of a group that includes the esophagus, the lower esophageal sphincter, and the stomach when the apparatus in being placed within the body of the mammal. 
     
     
       6. The apparatus of  claim 5 , wherein the apparatus includes a plurality of manometric measurement ports, the plurality of manometric measurement ports including at least one disposed about the distal end of the apparatus and at least one generally disposed adjacent the first extendable member. 
     
     
       7. The apparatus of  claim 1 , further including at least one pressure measurement device. 
     
     
       8. The apparatus of  claim 7 , further comprising a data processor adapted to analyze data obtained from the second expandable member to determine the sufficiency of the compliance of the sphincter. 
     
     
       9. The apparatus of  claim 1 , wherein the compliance measurement catheter includes a pattern of indicia distributed therealong for indicating correct placement of the second extendable member within the sphincter of the mammal. 
     
     
       10. An apparatus for measuring the compliance of a sphincter of a mammal comprising: 
       a compliance measurement catheter further comprising a length of tubing having a first end, a second end, and a plurality of lumens extending at least substantially therealong;  
       a first balloon disposed about the length of tubing; and  
       a second balloon located proximate to the first balloon along the length of tubing, the second balloon comprising a substantially non-elastic material and is sized and configured such that the second extendable member is inflatable to at least substantially contact the inner walls of the sphincter, the second balloon further comprising at least one manometric measurement port disposed therein for obtaining a measurement of compliance of the sphincter when the compliance measurement catheter is connected to a measurement device, the first balloon being positioned along the compliance measurement catheter such that when the second balloon is located within the sphincter, the first balloon resides in an adjacent body lumen, the first balloon being adapted to contact the inner surface of the adjacent body lumen when manipulated by an operator, thereby triggering a physiologic response by the adjacent sphincter.  
     
     
       11. The apparatus of  claim 10 , wherein the second balloon is sized and configured for placement in a lower esophageal sphincter of a human patient, the second balloon adapted to be inflated while inside the lower esophageal sphincter using an amount of a fluid such that a pressure reading results from the degree of compliance of the lower esophageal sphincter when the apparatus is connected to a pressure measurement device, whereby increasing amounts of fluid produce a series of pressure readings that can be used to indicate sufficiency of the compliance of the sphincter. 
     
     
       12. The apparatus of  claim 1 , wherein the first balloon is positioned within the esophagus of the patient when the intrasphincteric balloon is located within the lower esophageal sphincter. 
     
     
       13. The apparatus of  claim 11 , wherein the second balloon is generally oblong in shape. 
     
     
       14. The apparatus of  claim 12 , further comprising a third balloon located distal of the first and second balloons and adapted for correctly positioning the second balloon within the lower esophageal sphincter following deployment of the third balloon within the stomach of the patient and against the stomach wall proximate the LES. 
     
     
       15. The apparatus of  claim 10 , wherein the length of tubing further includes at least one manometric measurement port disposed therealong, the at least one manometeric measurement port so positioned for measuring the internal pressure found within at least one of a group that includes the esophagus, the lower esophageal sphincter, and the stomach when the apparatus in being placed within the body of the mammal. 
     
     
       16. The apparatus of  claim 15 , wherein the apparatus includes a plurality of manometric measurement ports includes at least one disposed about the distal end of the apparatus for measurement of pressure within the stomach and at least one generally disposed adjacent the first balloon member for measurement of pressure within the esophagus. 
     
     
       17. An apparatus for measuring the compliance of a sphincter of a mammal comprising: 
       a compliance measurement catheter further comprising a length of tubing having a first end, a second end, and a plurality of lumens extending at least substantially therealong;  
       a first balloon comprising an elastic material, the first balloon disposed about the length of tubing;  
       a second balloon comprising a non-elastic material and having a generally oblong shape, the second balloon located proximate to the first extendable member along the length of tubing;  
       a third balloon located distal of the first and second balloons and adapted for correctly positioning the second balloon within the lower esophageal sphincter following deployment of the third balloon within the stomach of the patient;  
       a plurality of manometric measurement ports disposed along the length of the tubing adapted to obtain pressure measurement within the esophagus and the stomach, the second extendable member being sized and configured such that the second extendable is inflatable to at least substantially contact the inner walls of the sphincter, the second balloon further adapted for obtaining a measurement of compliance of the sphincter when the compliance measurement catheter is connected to a measurement device, and the apparatus configured with the first balloon being positioned along the catheter such that when the second balloon is located within the sphincter, the first balloon resides in an adjacent body lumen, the first extendable member being adapted to contact the inner surface the adjacent body lumen when manipulated by an operator, thereby triggering a physiologic response by the adjacent sphincter.